Total records
16,790
Drug Enforcements
Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.
Most recent report
September 24, 2025
Last updated
September 30, 2025
Drug Enforcement Records
Sorted by most recent report date.
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Page 24 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-0055-2025 | Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3 | Noven Pharmaceuticals Inc | Ongoing | Class II | Nov 27, 2024 |
| D-0054-2025 | Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India | Lupin Pharmaceuticals Inc. | Ongoing | Class II | Nov 27, 2024 |
| D-0058-2025 | Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01 | Safecor Health, LLC | Ongoing | Class II | Nov 27, 2024 |
| D-0053-2025 | Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India | Lupin Pharmaceuticals Inc. | Ongoing | Class II | Nov 27, 2024 |
| D-0060-2025 | Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01 | Safecor Health, LLC | Ongoing | Class II | Nov 27, 2024 |
| D-0057-2025 | Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01 | Safecor Health, LLC | Ongoing | Class II | Nov 27, 2024 |
| D-0056-2025 | Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01 | Safecor Health, LLC | Ongoing | Class II | Nov 27, 2024 |
| D-0046-2025 | Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10 | Keystone Industries | Ongoing | Class II | Nov 20, 2024 |
| D-0044-2025 | Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90 | Cipla USA, Inc. | Ongoing | Class II | Nov 20, 2024 |
| D-0042-2025 | Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009 | Trinity Gold Nutrition | Ongoing | Class II | Nov 20, 2024 |
| D-0043-2025 | Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98 | Cipla USA, Inc. | Ongoing | Class II | Nov 20, 2024 |
| D-0040-2025 | Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317 | Staska Pharmaceuticals, Inc. | Terminated | Class I | Nov 13, 2024 |
| D-0034-2025 | Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018 | Denison Pharmaceuticals, LLC | Ongoing | Class III | Nov 13, 2024 |
| D-0035-2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. | FDC Limited | Ongoing | Class II | Nov 13, 2024 |
| D-0039-2025 | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01 | Baxter Healthcare Corporation | Ongoing | Class II | Nov 13, 2024 |
| D-0033-2025 | Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155 | Denison Pharmaceuticals, LLC | Ongoing | Class III | Nov 13, 2024 |
| D-0037-2025 | Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01. | Dr. Reddy's Laboratories, Inc. | Ongoing | Class II | Nov 13, 2024 |
| D-0036-2025 | Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01. | Dr. Reddy's Laboratories, Inc. | Ongoing | Class II | Nov 13, 2024 |
| D-0041-2025 | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles). | Direct Rx | Ongoing | Class II | Nov 13, 2024 |
| D-0038-2025 | Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. | VIONA PHARMACEUTICALS INC | Ongoing | Class II | Nov 13, 2024 |
| D-0030-2025 | Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. | ACCORD HEALTHCARE, INC. | Ongoing | Class II | Nov 6, 2024 |
| D-0032-2025 | Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. | ACCORD HEALTHCARE, INC. | Ongoing | Class II | Nov 6, 2024 |
| D-0026-2025 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30. | Dr. Reddy's Laboratories, Inc. | Ongoing | Class II | Nov 6, 2024 |
| D-0027-2025 | Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30. | Dr. Reddy's Laboratories, Inc. | Ongoing | Class II | Nov 6, 2024 |
| D-0028-2025 | Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30. | Dr. Reddy's Laboratories, Inc. | Ongoing | Class II | Nov 6, 2024 |